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Oviya MedSafe - UK FPM Article, Indian Pharmacovigilance Legislation & DIA Speakership

Dear Well-wishers,

As we get back to work after our Easter breaks, I feel rejuvenated to articulate my thoughts to compose this March 2016 edition of Oviya MedSafe’s newsletter focusing on a significant Indian development of international interest!

It was a moment of pride when the Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom invited me to share my perspectives on the evolution of pharmacovigilance in India. The obviously daunting exercise warranted a good deal of hard work, which I put in with the help of my colleague Dr Vignesh Rajendran. The result was a comprehensive article titled ‘Pharmacovigilance in India – The Past, Present and Future‘ elaborating on the advancements the country has seen in various aspects of the discipline and emphasizing the scope for leveraging the benefits of synergy among all the relevant stakeholders such as pharmaceutical companies, professional bodies, pharmacovigilance service-providers, healthcare professionals, consumers, regulators, the national pharmacovigilance programme, etc. The article has been published in FPM’s Spring 2016 Newsletter – a special issue on pharmacovigilance released on 30-Mar-2016 and is accessible through this link. I hope you will find this article informative and am keen to hear your feedback.

Interestingly, the article happens to be the first independent report of a key revolution that has happened in the history of pharmacovigilance in India, namely the Government of India mandating pharmacovigilance as a legal obligation for the pharmaceutical industry. The Gazette of India vide notification number GSR 287(E) dated 08-Mar-2016 necessitates applicants (drug manufacturers/marketers) to have a pharmacovigilance system in place and also hints at the qualification & training requirements for the personnel managing the system. This document is available on the website of Central Drugs Standard Control Organization (CDSCO – India’s Drug Regulatory Agency) in their Notification/Circulars/Publications section. Please scroll down to the last two pages of the PDF document to read the English version of the gazette notification.

The impact of this gazette notification could be better interpreted in conjunction with the Office Order dated 18-May-2015 requesting the pharmaceutical industry to submit ICSRs in XML-E2B format to the Pharmacovigilance Programme of India (PvPI), which was discussed in detail in Oviya MedSafe’s February 2016 newsletter. At this juncture, it is pertinent for me to state that Oviya MedSafe, which has already been contracted by several pharmaceutical companies for their Indian as well as global compliance, has well-established structure and systems to comply with the growing pharmacovigilance obligations in India, which may benefit you too.

India’s rising prominence in the international pharmacovigilance arena and the growing significance of technology-driven initiatives in patient safety management call for intense interaction among drug safety professionals from across the globe, which has been duly facilitated by the Drug Information Association (DIA) by organizing a conference titled ‘Innovations in Pharmacovigilance – the era of e-PV‘ at Mumbai, India on 13th & 14th May 2016. I owe my thanks to DIA for inviting me to join the Program Committee of the conference and play an active role in chiselling the event agenda along with some of my colleagues of repute in the industry. I have also been requested to moderate a session titled ‘Destination India – PV Outsourcing‘, which I am quite enthusiastically working on.

Speaking of conferences, it is my duty to also emphasize the Indian Pharmacovigilance Day 2016 and UK Pharmacovigilance Day 2016 conferences, which are to be chaired by me. The Indian Pharmacovigilance Day conference is to be organized for the first time on Friday 22-July-2016 at Mumbai, in follow up to the Pharmacovigilance Day series of events conducted in different parts of Europe. The conference is being conceptualized to be unique in its own way and the registrations are expected to be opened up in due course. The UK Pharmacovigilance Day 2016 conference is scheduled to be held on 18-Oct-2016 at London for the second time, following the success of UK Pharmacovigilance Day 2015 which too was chaired by me. It will be my pleasure to meet you at these conferences on which I intend to share more information in the forthcoming newsletters.

Looking forward to meeting you through our April 2016 newsletter with a different set of thoughts,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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